Since 2017, the annual ISPE Pharma 4.0™ Conference has been a trusted space for life science professionals to answer a lot of these questions. This year’s conference—taking place in Barcelona, Spain, and virtually on 9–10 December—continues that tradition of pragmatic, actionable learning.
What to Expect at the 2025 ISPE Pharma 4.0™ Conference
The 2025 ISPE Pharma 4.0™ Conference is designed to help attendees embrace digital transformation in a holistic way—not as a technology project only, but as a cultural and organizational journey. Over two days, the agenda features four inspirational keynotes from leading pharmaceutical companies, plus 32 practical case studies presented by selected industry experts from around the world.
Sessions are organized into eight focused tracks that cover the most urgent themes in digital transformation today:
- AI Case Studies: Benefits and Challenges: Real-world stories of AI adoption in quality, manufacturing, lab and global investigations
- Data-Driven Decision-Making & Manufacturing Excellence: How companies are structuring their data to drive efficient and agile, but resilient supply chains.
- Smart Validation: Innovative approaches to CSV and CSA in the ever changing
- Process Analytical Technology (PAT): How PAT serves as an enabler for robust transformation
- Data-Driven Quality Decisions: How reliable data drives the best quality decisions.
- Automation & Advanced Robotics: How to operationalize the next generation of intelligent automation
- Innovative Facility Design: Designing flexible, future-ready facilities aligned with Pharma 4.0™ principles
- Preparing for the Future: What’s next?
Insights from Teresa Minero, Chair, 2025 ISPE Pharma 4.0™ Conference: “What I particularly appreciate about this year's event is the structure: each track is designed as an interactive workshop, where speakers will deliver focused, impactful talks before joining session leaders on stage for an engaging and productive question-and-answer session with the audience. I’d also like to highlight a special initiative: the ‘Shaping the Future of Pharma: The Next Generation Meets AI’ session curated by ISPE’s Women in Pharma® and ISPE Emerging Leaders communities. This session will feature an innovative format that invites attendees to experience firsthand how the next generation is engaging with AI—not just in theory, but in action.”
Regulatory Insights That Matter
Transformations in pharma cannot happen in isolation—they must align with evolving regulatory frameworks.
On day one, Ib Alstrup, Medicines Inspector, GxP IT, of the Danish Medicines Agency, will deliver a keynote exploring how recent and upcoming regulations are designed to support industry with digital transformation. On day two, a panel of industry experts and regulators will discuss how to balance innovation and compliance. Attendees will leave with a clearer understanding of how to avoid common barriers, remediate risks, and engage regulators as partners in transformation.
Networking Designed for Real Conversations
One of the most valuable aspects of any ISPE event is the networking environment. At the 2025 ISPE Pharma 4.0™ Conference, connections happen organically—in sessions, hallways, and the exhibit hall. The conversations often go straight to the heart of what matters:
- How did you secure the right budget for your digital transformation program?
- How did you succeed? Why did you fail? Where are you still struggling?
- How do you handle the inevitable “Mr. or Ms. No” inside your organization?
- Which partners and vendors have you found most trustworthy for successful projects?
These candid exchanges are what make ISPE’s conferences different. It’s not just about listening to some talks—it’s about exchanging ideas, it’s about having the possibility to ask questions in a professional but friendly environment, it is learning directly from peers having similar goals and facing the same challenges.
Minero shares, “At every ISPE conference, I meet someone who truly inspires me, someone else who teaches me something new, and I always discover innovative approaches and applications I would have never thought possible in the regulated pharmaceutical world. In short, by the end of every ISPE conference, I feel energized—not only because I now have more people I can reach out to whenever I face a challenge or a doubt, but also because I know that if they don’t have the answer themselves, they will gladly connect me with someone who does. And of course, I will do the same for all of them. All of that, to me, is one of the greatest feelings: being part of a global community where knowledge, support, and collaboration are always just a conversation away.”
Beyond the Sessions: The Exhibition Area
The exhibition area at Pharma 4.0™ is more than just a showcase—it’s where real-world challenges meet innovative solutions. Attendees will discover both emerging technologies and mature digital tools that companies are already using successfully. Exhibitors often bring practical, battle-tested models born out of day-to-day struggles in many life science-regulated domains.
For engineers, quality professionals, business and digital leads, and executives, this is a chance to evaluate technologies side-by-side and to discuss directly with vendors and consultants how they can be adapted to specific environments.
Shaping a Patient-Centric Digital Future
A core message of this year’s conference is that Pharma 4.0™ is not just about technology or data. It is about operational excellence, regulatory alignment, and ultimately, patient outcomes. The question we’ll ask together in Barcelona is: How can we transform our industry better, faster, and with less risk for the sake of patients?
This mindset is what makes Pharma 4.0™ different from other digital transformation movements. It’s not about chasing shiny objects or adopting every new technology. It’s about carefully integrating the right digital tools, agile and compliant processes, and an adequate cultural approach to deliver safe and effective medicines in a timely manner to the people who need them.
Why Attend?
By joining the 2025 ISPE Pharma 4.0™ Conference, attendees will:
- Gain firsthand insights from regulators, industry leaders, and peers on the frontlines of digital transformation
- Learn from concrete case studies that show what worked, what didn’t, and how challenges were overcome
- Build a network of trusted peers and partners who can help guide team initiatives
- Explore new technologies and approaches that are already proving their value in real-world settings
- Industry professionals will leave with actionable ideas to successfully operationalize a Pharma 4.0 program in any organization. Vendors or consultants will come back home with many ideas and opportunities.
Minero shares, “As Chair of the 2025 ISPE Pharma 4.0™ Conference, my wish is that everyone leaves with a brand-new toolkit to support a successful Pharma 4.0 transformation. This ’luggage’ should be fully equipped—with a clear understanding of why transformation is needed, what needs to change, how to make it happen, and who to connect with for support along the journey.
Closing Thoughts
In closing, Minero concludes, “As Chair, I believe this year’s Pharma 4.0™ Conference has the potential to leave a lasting mark on the global life sciences community. By combining practical insights, regulatory clarity, and candid peer-to-peer learning, we will equip attendees not just with knowledge, but with the tools and confidence to lead transformation within their own organizations.”
Digital transformation and specifically Pharma 4.0 is not an abstract future—it is happening here and now. The companies and professionals who engage with it thoughtfully will not only improve efficiency and compliance but also ensure that patients worldwide have timely access to safe and effective medicines.
Join ISPE in Barcelona or virtually this December to be part of this vital conversation. Together, we’ll move beyond theory and into action to quickly deliver all the benefits our stakeholders are expecting.
Register now.
